Randomized trials of tretinoin creams in photoaged skin report more improvement than vehicle or placebo on several measures, and the labels set clear limits. The Renova 0.02% label says the product does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Both are covered below, with the strength each source names.
What the labels say and do not say
| Label | What it says |
|---|---|
| Renova (tretinoin cream) 0.02%: use | Indicated as an adjunctive agent for the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. |
| Renova 0.02%: limits | Does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. |
| Tretinoin Cream, USP (Emollient) 0.05%: use | Indicated as an adjunctive agent for the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs. |
| Tretinoin Cream, USP (Emollient) 0.05%: limits | Effectiveness has not been established in people greater than 50 years of age or in people with moderately to heavily pigmented skin. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs. |
The two labels differ in wording and name different strengths. Both tie use to comprehensive skin care and sunlight avoidance programs.
What the trials measured
A 1988 JAMA study was a 16-week randomized, double-blind, vehicle-controlled study. All patients applied tretinoin to one forearm and vehicle cream to the other. The abstract also reports that 14 of the 15 patients who received tretinoin to the face had improvement in photoaging, whereas none of the vehicle-treated patients' faces improved, a statistically significant difference. The abstract does not state the tretinoin strength.
A 1992 J Am Acad Dermatol study was a 24-week, double-blind, randomized, multicenter study of 296 subjects with photodamaged facial skin. It compared three concentrations of tretinoin (0.05%, 0.01%, and 0.001%) in a new emollient cream formulation with vehicle. For the 0.05% cream, the abstract reports a significantly better global response than vehicle (p less than 0.001): 68% of subjects improved at the end of therapy, compared with 43% in the vehicle group. Results for 0.01% and 0.001% are not reported here.
A 2005 two-year, randomized, placebo-controlled trial treated 204 subjects with tretinoin or placebo (vehicle emollient cream) applied to the entire face once a day for up to 2 years. The strength, 0.05%, comes from the paper's title. The abstract reports significantly greater improvement with tretinoin than placebo in clinical signs of photodamage (fine and coarse wrinkling, mottled hyperpigmentation, lentigines, and sallowness), in overall photodamage severity, and in the investigator's global assessment of clinical response.
A 2004 multicenter, double-blind, randomized, parallel-group study reports that tazarotene 0.1% cream can offer superior efficacy over tretinoin 0.05% emollient cream in facial photodamage, particularly in speed of improvement. The comparison is with a different product.
What reviews report
The abstract of a Cochrane review (2005; literature searched to June 2002) reports that eight trials showed topical tretinoin cream, in concentrations of 0.02% or higher, was superior to placebo for mild to severe photodamage on the face and forearms. It adds that losses to follow-up were relatively high in most studies. It concludes there is conclusive evidence that topical tretinoin improves the appearance of mild to moderate photodamage on the face and forearms in the short term. It also states that erythema, scaling/dryness, burning/stinging and irritation may be experienced initially.
A 2022 systematic review of randomized controlled trials lists as limitations that different tretinoin formulas, different outcome parameters, and limited recent studies cause lack of uniformity in the evidences.
What this does not tell you
Labels and trials cover different strengths: 0.02%, 0.05%, and (in one Cochrane sentence) 0.02% or higher. The Cochrane conclusion sentence and the 1988 abstract name no strength. Results should not be merged.
Vehicle-group results vary. None of the vehicle-treated faces improved in the 1988 study. In the 24-week study, 43% of the vehicle group improved. The Tretinoin Cream, USP (Emollient) 0.05% label says many patients in the vehicle group achieved desired palliative effects in its double-blinded, vehicle-controlled studies.
These are group results from abstracts and labels. They do not predict what any one person will see or choose a strength for anyone. A licensed provider decides that.
The FDA page Compounding and the FDA: Questions and Answers says compounded drugs are not FDA-approved, meaning FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. None of the results above shows the same strength, quality or result for a compounded cream.